Catheters which are implanted in the body of a patient for an extended period of time are used for intravenous therapies such as parenteral nutrition, chemotherapy for cancer treatments, bone marrow transplants, intravenous antibiotics, blood products and other fluids, and the like, as well as for blood withdrawal. Heretofore, the externally extending tubing portion of the implanted tubing and the free end, which extended from an exit site on the body, was usually either taped to the body, the cap was taped and pinned to the patient's clothing, or the tubing was wrapped to the patient's body with such materials as tube gauze, burn netting, or elastic bandages (e.g., Ace bandages) to prevent displacement and dislodgement of the tubing and to allow maintenance therein of the proper blood or nutrition levels or to administer medication intravenously. To use the catheter or other tubing, for example, to introduce additional fluid into the body when tape is used to secure the catheter, it is first necessary to remove the tape securing the catheter or other tubing to the body or clothing. This removal of the tape and retaping to the body each time the catheter was to be used, and at least daily to allow the line to be flushed to prevent clogging, can result in irritation of the skin. Using tape to secure the catheter or other tubing to the body is unsuitable because, in addition to the potential for skin irritation and allergic reaction, as well as for infection from the breakdown of the skin, the taping does not afford the desired freedom of movement of the patient without fear of dislodging the catheter. Moreover, when the end of the catheter taped and pinned is visible from the outside of the clothing, it presents an unsightly and disturbing appearance which can produce mental distress in sensitive patients and children.
Similarly, feeding tubes which are implanted in the body of a patient for an extended period of time are used to administer enteral nutrition directly into the stomach or small intestine of the patient. These tubes typically exit the body on the left side in an area below the rib cage. Heretofore, any externally extending tubing portions of the implanted tubing were usually taped to the body, as were catheters. Also, similarly, heretofore surgical drains which were implanted in the body following surgery were usually taped to the body or taped and/or pinned to the patient's clothing.
Wires with electrodes for electrocardiograph units, or for heart monitors, were generally attached to the body merely at the point to be measured. A transmitter which stores the data, a box measuring approximately 3".times.5", was held next to the patient's body by a cord tied around the patient's neck. When the transmitter is inadvertently moved during sleep or normal activity, it could move the wires and pull off the electrodes that attach the wires to the skin. Similarly, pumps used to dispense intravenous medications through central venous catheters were likely to pull on the exit side of the catheter.
Previous makeshift devices mentioned above, such as burn gauze, burn netting and elastic bandages, do not adequately secure the catheter and/or other types of tubing or cables, as they do not remain in place, and they lose their shape in a short period of time. While these devices may secure the catheter initially, they are not sufficient to maintain the catheter in place when the patient moves.
Conventional means of securing a catheter and/or other types of tubing or cables to the body do not protect the exit site of the tubing, nor does it prevent dislodgement and accidental removal of the catheter and/or tubing or cables. This is particularly a problem for young patients or for those patients who cannot control their movements, such as during sleep, or disoriented patients or patients who may purposefully move the body about in an excessive manner, such as patients with spastic muscles. These movements disturb the catheter exit site and may dislodge the catheter or other tubing, or displace the internally implanted tubing portion of the catheter, while also possibly aggravating and causing inflammation of the exit site. When the catheter or other tubing is taped to the body for retention, usually it is not possible to use the end of the external portion of the catheter without removing the tape retention means and reapplying the tape to the body or to the cap(s), which must be taped or pinned to clothing after each use of the catheter.
Once a catheter or other type of tubing is implanted, it need not be subjected to intervention over extended periods to time. Thus, it is important that the external portion and its end be stored out of sight and securely retained for permitting the desired freedom of the patient, while still providing ready access to the catheter or tubing should the need arise.
A number of attempts have been made to provide an alternative to taping a catheter to a patient's body, all with limited success. The most glaring omission of the previous attempts is that none of them has been successful in securing the catheter against both horizontal and vertical motion.
Daneshvar, in U.S. Pat. No. 5,336,195, discloses a wrapping unit for encircling a portion of the body which includes a support on the wrap for releasably holding an invasion apparatus, such as a catheter, on the wrap. Daneshvar uses a tray which has a plastic cover or strap which covers the trap, permitting the catheter to move horizontally. There is nothing in this unit to prevent the catheter from being moved either vertically or horizontally.
Pavelka, in U.S. Pat. No. 4,582,508, discloses a garment for holding, supporting and storing an indwelling catheter. A second body attachment element extends over the patient's shoulder. The pocket, however, does not secure the catheter to the body, and, therefore, the catheter can be moved out of position. The catheter is coiled and inserted into the pocket, rather than lying flat against the body. This coiling can possibly cause the catheter to pull on the incision in the body. The pocket must be detached to permit access to the catheter for, e.g., flushing, changing the dressing, administering medication such as chemotherapy, etc. Body protrusions such as breasts, may interfere with the ability of the pocket and straps to lie flat against the body. This garment does not appear to have a means to be put on and removed without disconnecting the infusion tubing, thereby increasing the risk of infection that is created by having to disconnect and reconnect the infusion tubing. Additionally, this garment does not provide a reliable way to secure feeding tubes or surgical drains, as they cannot be coiled to fit into a pocket without putting so much tension on the exit site that there is a danger of dislodging the tubing and, in the case of feeding tubes, causing granular tissue to build up around the exit site on the body.
McNeish et al., in U.S. Pat. No. 4,666,432, disclose a catheter retaining means and method for a surgically implanted catheter comprising a band of flexible material for being received about the body and over the exit site of the implanted catheter for protecting the body and retaining the tubing in position. The band has an opening and a pocket overlying the opening for receiving at least a part of the external tubing into the opening and for storing the free end therein. The catheter may be coiled to fit into the pocket, which may cause the catheter to pull on the incision in the body. This garment also appears to prevent a female wearer from wearing a separate brassiere at the same time as she wears the garment. As there is no easy means for ingress to the catheter exit site, the McNeish garment must be removed for dressing changes over the exit site. This garment does not appear to have a means to be put on and removed without disconnecting the infusion tubing, thereby increasing the risk of infection that is created by having to disconnect and reconnect the infusion tubing. Moreover, this garment does not provide a reliable way to secure feeding tubes or surgical drains, as they cannot be coiled to fit into a pocket without putting so much tension on the exit site that there is a danger of dislodging the tubing and, in the case of feeding tubes, causing granular tissue to build up around the exit site on the body.
Madden et al., in U.S. Pat. No. 5,244,464, disclose a band for securing and aligning medical tubing to the body. However, this device is merely a band which encircles the mid-section of a patient, and there is no vertical support for the band to secure a chest catheter or other tubing to prevent the catheter or other tubing from moving either vertically or horizontally.
Bird et al., in U.S. Pat. No. 5,352,209, disclose a band for securing a tube device to a limb or other body member comprising a primary stretchable strap which is secured about a body member and a secondary strap to retainably engage the tube. This device has no vertical support for a chest catheter to prevent the catheter from being moved either vertically or horizontally.